An Overview of Edurant (Rilpivirine)

Brand Name: Edurant
Other Name(s): RPV, rilpivirine hydrochloride
Drug Class: Non-nucleoside Reverse Transcriptase Inhibitors
Approved Use: Treatment of HIV Infection

What is rilpivirine?

Rilpivirine is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults who have never taken HIV medicines before and who have a viral load (number of HIV RNA copies per mL of blood) of 100,000 copies/mL or less at the start of treatment. Rilpivirine is always used in combination with other anti-HIV medicines.

Rilpivirine is a type of anti-HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI). NNRTIs work by binding to and blocking HIV reverse transcriptase, an HIV enzyme. This prevents HIV from replicating and lowers the amount of HIV in the blood.

Rilpivirine does not cure HIV/AIDS. It is not known if rilpivirine reduces the risk of passing HIV to other people.

What should I tell my health care provider before taking rilpivirine?

Before taking rilpivirine, tell your health care provider:

• If you are allergic to rilpivirine or any other medicines.
• If you have had or currently have liver problems, including hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• If you have ever had a mental health problem.
• If you are pregnant or plan to become pregnant. Whether rilpivirine can harm an unborn baby is unknown.
• If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking rilpivirine.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Rilpivirine may affect the way other medicines or products work, and other medicines or products may affect how rilpivirine works. Taking rilpivirine with certain medicines or products may cause serious side effects.

How should I take rilpivirine?

Rilpivirine comes in one form:

• 25-mg tablets (brand name: Edurant).

Take rilpivirine according to your health care provider's instructions.

Always take rilpivirine with a meal. (A protein drink alone does not replace a meal.)

Always take rilpivirine in combination with other anti-HIV medicines.

If you take too much rilpivirine, contact your local poison control center (1-800-222-1222) or go to the nearest hospital emergency room right away.

For more information on how to take rilpivirine, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)

What should I do if I forget a dose?

If you miss a dose of rilpivirine within 12 hours of the time you usually take it, take your dose with a meal as soon as possible. Then take your next dose at the regularly scheduled time. If you miss a dose by more than 12 hours from the time you usually take it, wait and then take the next dose at the regularly scheduled time.

What side effects can rilpivirine cause?

Rilpivirine can cause serious, life-threatening side effects. These include depression or mood changes. (See the WARNING above.)

Other possible side effects of rilpivirine include:

• Changes in body fat (lipodystrophy).
• Changes in the immune system (immune reconstitution inflammatory syndrome).
• Kidney problems, including kidney stones (nephrolithiasis) and nephrotic syndrome.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of rilpivirine. Ask your health care provider or pharmacist for more information on possible side effects of rilpivirine.

How should rilpivirine be stored?

• Store rilpivirine between 59°F and 86°F (15°C to 30°C).
• Keep rilpivirine in the original bottle to protect the tablets from light.
• Safely throw away rilpivirine that is no longer needed or expired (out of date).
• Keep rilpivirine and all medicines out of reach of children.

Where can I find more information about rilpivirine?

More information about rilpivirine is available:

• The rilpivirine drug label, from DailyMed. The Patient Counseling Information section of the label includes information for people taking rilpivirine.
• Rilpivirine-related research studies, from the AIDSinfo database of ClinicalTrials.gov study summaries.
• A list of FDA-approved generics for anti-HIV medicines, from FDA.

Manufacturer Information

Janssen Pharmaceuticals, Inc.
800-526-7736